Evaluating a Contract Research Organization (CRO) for your
clinical project may seem like a daunting task. You may begin
with the internal assessment of the research project(s) to
determine which activities may be done in-house and which
will be outsourced. Then, there is the need to identify a
manageable number of appropriately experienced CROs to request
proposals. Finally, CRO capabilities and proposals must be
compared to assess the most appropriate partner for your project.
CRO options range from large, publicly owned companies with
comprehensive services and global coverage to privately-owned
niche providers with specialized services. CRO services and
budgets often vary significantly with respect to details and
assumptions, which makes comparisons difficult. And, the CRO
employees you talk with or meet may not be the ones assigned
to your project.
To facilitate an efficient, effective evaluation of CROs,
Promedica International (PMI) has compiled the following suggestions
for your consideration.
It seems obvious that you would only consider CROs
offering the services you need. However, don’t accept
things at face value – check to confirm mutual understanding
of the activities included in each service, as well as any
applicable geographical considerations. Check, also, if the
CRO’s services are all provided by CRO employees/subsidiaries,
or via alliances with niche service providers – having
everything “under one roof” may facilitate project
management, but niche service providers often outperform a
large CRO in their designated area of expertise.
You might also ask for and consider the CRO’s suggestions
regarding services that may facilitate more efficient completion
of your project.
Related Experience – Similar Projects
Related project experience at the CRO often translates
into program efficiencies for you – in procedures, work
templates, resource networking, and team training. If the
CRO does not have directly related project experience, you
might ask for metrics regarding other projects that may be
similar in terms of trial design, subject demographics, and
medical practice patterns.
Related Experience – Similar Clients
Sponsor companies have a variety of organizational
cultures and structures. Early stage companies often have
a singular focus on the status of their trial and the need
to know details regarding trial activities at any given time
– they typically want a fast response and creative problem-solving.
Established companies may delegate the trial and request
only periodic status reports – they may place a higher
priority on procedural rigor than speedy response. What is
your company’s culture? Does this CRO have experience
working with companies similar to yours?
The CRO business involves significant business risk;
e.g., regulatory approvals may be delayed, products may not
be sufficiently efficacious to proceed to the next study phase,
and sponsors sometimes change business strategies that may
result in project cancellations. You want to feel comfortable
that the CRO is financially strong enough to withstand business
downturns while providing appropriate attention to your project.
How long has the CRO been in business? Is their project
portfolio sufficiently diversified to mitigate the risks described
above? What practices does the CRO utilize to facilitate sound
cash flow management?
Employee Training, Experience, and Stability
What are the educational and professional backgrounds
of the CRO’s employees? Do they have sufficient experience
and training in Good Clinical Practice to perform assigned
project tasks effectively? Also, project team turnover generates
additional expense and inefficiency. What metrics can the
CRO provide regarding employee retention?
Delivery of Services
“How does a project get to be a year behind
schedule? – One day at a time.”1 Take time to
understand how the CRO delivers their services and evaluate
how their systems will integrate into those of your company.
Who at the CRO is responsible for managing the project schedule
and budget? Who supervises the project team? Who at the CRO
is ultimately responsible for your project? Did you have a
chance to meet and talk with the key person(s) who would be
working on your project? Generally, a single point of contact
facilitates clearer communication.
How detailed is the project budget provided by the CRO?
Did they take sufficient time to review the budget so that
you can verify concurrence of assumptions and general plans?
How often does the CRO invoice and how well does the invoice
format match the budget provided? What sort of budget reports
can the CRO provide?
What is the CRO’s typical format for reporting and
monitoring on the project schedule? Does the CRO have a comprehensive
checklist of tasks required for clinical trials?
1Fred Brooks, Software Engineer and Author
Track Record – Budget/Schedule
Because of the uncertainties associated with conducting
human clinical trials, many project budgets and schedules
may be revised once or more after project initiation. How
does the CRO handle this? Are they proactive in identifying
and addressing deviations? You may want to get the names of
client references you can talk with to get additional data
about the CRO’s performance this area.
Track Record - Client Satisfaction Client satisfaction is
important data for evaluation of the CRO’s performance;
however, be careful not to base your entire assessment on
feedback from only one client. Does the CRO have a formal
method for monitoring client satisfaction across projects?
If so, how often is this assessed and what metrics can the
CRO provide? Again, you may want to get the names of client
references you can talk with to get additional feedback about
their experience working with this CRO.
Appropriate CRO infrastructure is essential to support
your project requirements.
Does the CRO have adequate facilities and staff to handle
your project requirements? What software is used to track
project performance? How is the clinical information system
organized? - Is clinical data maintained in accordance with
21 CFR Part 11? What steps must be taken to export data maintained
at the CRO into your company’s system? What mechanism
does the CRO provide to facilitate sponsor review of clinical
study data? How does the CRO manage essential study documentation?
Quality assurance is essential to good clinical research
practices. Decisions regarding product safety and efficacy
are based on the assumption of study integrity.
What methods does the CRO use to implement their services
and confirm the quality of their work? What experience does
the CRO have with FDA or other applicable regulatory authorities?
Have they been audited by any of these authorities? If so,
what was the result? If observations were noted, what has
the CRO done to address these observations? Does the CRO have
any additional quality assurance credentials; e.g., ISO certification?